Preclinical characterization and safety of a novel hydrogel for augmenting dural repair

Cerebrospinal fluid (CSF) leakage is a potentially serious complication in surgical procedures involving opening of the dura mater. Although several materials have been developed to help achieve watertight dural closures, CSF leakages persist. The goal of this study was to evaluate the performance of a novel hydrogel designed to provide augmentation to standard methods of dural repair. Performance measures such as polymerization time, dimensional swelling, burst strength, and elasticity were examined in laboratory situations. Additionally, biocompatibility in an in vivo rat model was examined. The results demonstrate that this novel hydrogel has superior mechanical strength and tissue adherence with enhanced flexibility, reduced swelling, and quicker set time compared with existing hydrogel dural sealants approved for intra-cranial use. Furthermore, biocompatibility studies demonstrate that this compound is both non-toxic and non-immunogenic.